Human Xtensions is a rapidly growing startup, developing breakthrough technology in the field of robotic Minimally Invasive Surgery (MIS). We’re looking for an awesome QA Engineer to join our core QA team that is reshaping MIS.
Being a QA focal point for productions routine activities; ensuring the quality system requirements are effectively maintained for regulatory and legal compliance
- Work closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews and non-conformances.
- Support of product repair activities.
- Ensure quality processes and records are analyzed, to assure products are manufactured and maintained according to specifications
- Initiate, lead and execute NCR & corrective and preventive actions (CAPA)
- ECO execution and approval
- Trending production related data.
- Prepare for external audits and execute internal audits.
- DHRs review and approval
- Supervise production related activities (Storage handling, Incoming inspection process, Environmental monitoring, ESD, Sterilization)
- Support supplier evaluation process and control over their performances.
- Support additional QA assignments: review and approval of validations process and QMS related process.
- 3+ years relevant experience in the medical device industry
- Bachelor’s degree (engineering education)
- Previous experience as QA Engineer
- guiding of qualification and validation activities (IQ, OQ & PQ , V&V testing, BT) Must be knowledgeable in quality affairs.
- Acquaintance with e-Document management systems – advantage
- English – high level (written and spoken)
- Detail-oriented, dependable and trustworthy
- Ability to evaluate, prioritize, organize, multitask and problem solving